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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 19 March 2012
Main ID:  EUCTR2005-002510-38-HU
Date of registration: 09/11/2005
Prospective Registration: Yes
Primary sponsor: AstraZeneca AB
Public title: A Randomised, Double-Blind, 52-Week, Parallel-Group, Multicentre, Phase IIb Study to Evaluate the Effects of Rosuvastatin 10 mg, Rosuvastatin 40 mg and Atorvastatin 80 mg on Urinary Protein Excretion in Hypercholesterolaemic Diabetic Patients with Moderate Proteinuria PLANET I: Prospective evaLuation of proteinuriA and reNal function in diabETic patients with progressive renal disease - PLANET I
Scientific title: A Randomised, Double-Blind, 52-Week, Parallel-Group, Multicentre, Phase IIb Study to Evaluate the Effects of Rosuvastatin 10 mg, Rosuvastatin 40 mg and Atorvastatin 80 mg on Urinary Protein Excretion in Hypercholesterolaemic Diabetic Patients with Moderate Proteinuria PLANET I: Prospective evaLuation of proteinuriA and reNal function in diabETic patients with progressive renal disease - PLANET I
Date of first enrolment: 19/12/2005
Target sample size: 345
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002510-38
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: study drug encapsulated for blinding If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: yes Other specify the comparator: comparator encapsulated for blinding  
Phase: 
Countries of recruitment
Denmark Hungary Italy
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
For inclusion in the study lead-in period at Visit 1, patients must fulfil all of the following
criteria:
1. Provision of written informed consent
2. Male or female aged =18 and =70 years
3. Type 1 or 2 diabetes
4. Fasting LDL-C levels collected at Visit 1:
=90 mg/dL (2.33 mmol/L) and =180 mg/dL (4.66 mmol/L) if statin naïve (have
not received statin treatment for =6 weeks prior to study entry)
=70 mg/dL (1.81 mmol/L) and =145 mg/dL (3.75 mmol/L) if receiving
lovastatin, fluvastatin, or pravastatin at study entry
=60 mg/dL (1.55 mmol/L) and =120 mg/dL (3.11 mmol/L) if receiving
simvastatin or atorvastatin at study entry
5. Proteinuria of =2+ on urine dipstick at Visit 1
6. Treatment with ACE inhibitor and/or an ARB for =3 months prior to Visit 1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. History of statin intolerance, statin-induced myopathy, or serious hypersensitivity
reaction to other HMG-CoA reductase inhibitor (statin)
2. Previous rosuvastatin use at any time
3. Pregnant women, women who are breast feeding, and women of childbearing
potential who are not using chemical or mechanical contraception or have a positive
serum pregnancy test
4. Patients having one or more of the following events within 12 weeks of V1: a
myocardial infarction, unstable angina, myocardial revascularization (percutaneous
transluminal coronary angioplasty, coronary artery bypass graft surgery or another
revascularization procedure) or a transient ischemic attack (TIA) or stroke
5. Moderate to severe congestive cardiac failure (New York Heart Association
[NYHA] Class III or IV) (
6. Patients awaiting a planned myocardial revascularization prior to starting the study
7. History of malignancy (unless a documented disease-free period exceeding 5 years
is present) with the exception of basal cell or squamous cell carcinoma of the skin.
Women with a history of cervical dysplasia would be permitted to enter the study
provided they have 3 consecutive clear Papanicolaou (Pap) smears
8. Uncontrolled hypothyroidism defined as a thyroid stimulating hormone (TSH)
>1.5 times ULN at Visit 1
9. Poorly controlled diabetes mellitus based on HbA1c =10% or fasting serum glucose =180 mg/dL at Visit 1
10. History of homozygous familial hypercholesterolaemia or known Type III
hyperlipoproteinemia (familial dysbetalipoproteinemia)
11. History of alcohol or drug abuse, or both in the last 5 years
12. Current active liver disease as defined by elevations of >2 x ULN in ALT at
Visits 1 or 3 or severe hepatic impairment
13. Unexplained creatine kinase (CK) > 2 x ULN at Visits 1 and 3
14. Participation in another investigational drug study <4 weeks before Visit 1 or in
accordance with local ethics if a longer period is stipulated. Patients who withdrew
from the treatment phase of this or a previous rosuvastatin study cannot re-enter this study
15. Serious or unstable medical or psychological conditions that, in the opinion of the
investigator, would compromise the patient’s safety or successful participation in
the study.
16. Patients whose hormone replacement therapy (HRT) or oral contraceptive therapy (OCT) was initiated or changed within the 3 months prior to Visit 1
17. Severe renal impairment, as judged by serum creatinine >2.0 mg/dL (177 µmol/L)
at Visit 3
18. Any known clinical condition that, in the opinion of the investigator, would require
an adjustment of the ACE inhibitor and/or ARBs during the 52-week treatment
period
19. Statin therapy after Visit 1. Patients may be either statin naïve or have undergone statin withdrawal at Visit 1
20. Bile acid sequestrant therapy after Visit 2
21. Underlying renal disease attributed to autosomal dominant polycystic kidney
disease, intersitial nephritis, HIV (human immunodeficiency virus) nephropathy or
ischemic renal disease (i.e. bilateral renal artery stenosis or unilateral renal artery
stenosis in a single kidney)
22. Asian ethnicity
23. Involvement in the planning and conduct of the study


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Male and female patients aged >= 18 and <=70 years with Type 1 or 2 diabetes, moderate proteinuria (baseline urinary protein/creatinine ratio >=500 mg/g and <=5000 mg/g), mild hypercholesterolaemia (fasting LDL-C >=90 mg/dL (2.33 mmol/L) and <180 mg/dL (4.66 mmol/L) and receiving current treatment with ACE (Angiotensin converting enzyme) inhibitors and/or ARBs (Angiotensin receptor blockers) for >=3 months prior to Visit 1.
Intervention(s)

Trade Name: Crestor 5mg
Product Name: Crestor 5mg encapsulated tablet
Product Code: AZD4522
Pharmaceutical Form: Film-coated tablet

Trade Name: Lipitor 40mg
Product Name: Lipitor 40mg encapsulated tablet
Pharmaceutical Form: Film-coated tablet

Trade Name: Crestor 10mg
Product Name: Crestor 10mg encapsulated tablet
Product Code: AZD4522
Pharmaceutical Form: Film-coated tablet

Trade Name: Crestor 20mg
Product Name: Crestor 20mg encapsulated tablet (2x 10mg)
Product Code: AZD4522
Pharmaceutical Form: Film-coated tablet

Primary Outcome(s)
Primary end point(s): The primary outcome variable (end point) is the change in urinary protein/creatinine ratio from baseline to Week 52.
Main Objective: The primary objective of this study is to evaluate the effects of rosuvastatin and atorvastatin on urinary protein excretion by evaluation of the change in urinary protein/creatinine ratio rom baseline to Week 52 in patients with Type 1 or 2 diabetes, moderate proteinuria and mild hypercholesterolaemia.
Secondary Objective: 1. to evaluate the effects of rosuvastatin and atorvastatin on urinary protein excretion by evaluation of the change in urinary protein/creatinine ratio
2. to evaluate the effects of rosuvastatin and atorvastatin on urinary albumin excretion by evaluation of the change in urinary albumin/creatinine ratio
3. to evaluate the effects of rosuvastatin and atorvastatin on: low-density lipoprotein
cholesterol (LDL-C), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG), nonHDL-C, apolipoprotein A1 (ApoA-1), apolipoprotein B (ApoB),
TC/HDL-C, LDL-C/HDL-C, nonHDL-C/HDL-C and ApoB/ApoA-1) to explore the
relationship between renal effects and lipid changes
4. to evaluate the effects of rosuvastatin and atorvastatin on renal function by evaluation of the change in estimated glomerular filtration rate (GFR) predicted from the Modification of Diet in Renal Disease (MDRD) [Levey et al 1999] equation
Secondary Outcome(s)
Secondary ID(s)
D3569C00007
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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